Apparatus and method for endoscopic colectomy

ABSTRACT

Apparatus and methods for endoscopic colectomy are described herein. A colectomy device having a first and a second tissue approximation device is mounted on a colonoscope separated from one another. During deployment of the colectomy device, a diseased portion of the colon is positioned inbetween the tissue approximation devices. The tissue approximation devices are radially expanded such that they contact and grasp the colon wall at two sites adjacent to the diseased portion of the colon. The diseased portion is separated from the omentum and is transected using a laparoscope or is drawn into the colonoscope for later removal. The tissue approximation devices are then urged towards one another over the colonoscope to approximate the two free edges of the colon into contact together where they are fastened to one another using the tissue approximation device as a surgical stapler to create an end-to-end anastomosis.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefits of priority to U.S.Provisional Patent Application Serial No. 60/347,674 filed Jan. 9, 2002,the entirety of which is incorporated herein by reference.

FIELD OF THE INVENTION

[0002] The present invention relates generally to surgical methods andapparatus. More particularly, it relates to methods and apparatus forperforming endoscopic colectomy.

BACKGROUND OF THE INVENTION

[0003] Endoscopy studies the intralumenal aspects of hollow organs ofthe upper and lower intestine including the esophagus, stomach and thecolon through cannulation of the lumen via the mouth or anus. Endoscopicpolypectomy is presently limited to a submucosal resection. Theendoscopist is often unable to completely resect a sessile polyp orlesion and therefore the patient is subjected to subsequent definitivesurgery, i.e. resection of the base of the tumor. Endoscopic polypectomycan be used to debulk sessile masses but it is unable to resect muraldisease. Incomplete resection of a sessile polyp may destroy the biopsyspecimen and alter the relationship of the gross specimen given to thepathologist thereby resulting in the pathologist possibly providingincorrect or incomplete study results. The endoscopist is also unable tocorrect uncommon, but life threatening, procedural complications such asperforations. Other cases where resection is required are invasivetumors, perforation from different causes, inflammatory bowel disease,diverticulosis and others.

[0004] Surgical approaches for resecting diseased tissue are largelypracticed by making large laparotomy incisions or using minimallyinvasive techniques such as laparoscopic surgery in which tissues areresected and repaired through small incisions.

[0005] There are numerous surgical devices enabling surgeons to resectdiseased tissue and subsequently anastomose remaining tissue eitherthrough a conventional incision or using a laparoscope and making one ormore relatively small incisions. Additionally, endoscopically assistedstapling devices are known which enable surgeons to remotely anastomoselumenal structures such as the bowel. Endoscopically assisted bowelanastomosis nevertheless typically requires extralumenal assistance viaa traditional laparotomy incision or use of a laparoscope.

[0006] Trends in surgery are towards minimally invasive procedures asevidenced by developments including laparoscopic cholecystectomy,laparoscopic appendectomy and laparoscopically assisted partialcolectomies and hernia repairs. All of these minimally invasiveprocedures involve introducing a laparoscope through the abdominal walland creating other associated openings to gain access to the peritonealcavity in order to perform the necessary surgical procedure. Typically,general anesthesia is required. Endoscopically possible proceduresinclude polypectomy, mucosectomy, and cauterization. During“laparoscopic colectomy” today the colon is separated from its omentumlaparoscopically and then the colon is exteriorized out of the abdominalcavity, through a laparotomy incision where the resection andanastomosis are performed extracorporeally.

[0007] Disadvantages of the laparoscopic method include the need totraverse the abdominal wall, increased operating time secondary to thelack of exposure for the procedure and possibly the need to convert toan “open” laparotomy in the course of performing the procedure.

[0008] Present stapling techniques in surgery are for the most partfunctionally adequate but limited. Devices exist including the GIA andEEA staplers which can be used to transect tissue in a linear orcircular fashion, respectively, with subsequent anastomosis withstaples. The linear GIA is relatively versatile. The EEA is primarilysuited for lower colonic circular anastomosis after a lesion has beensurgically removed (via laparotomy or laparoscopically) or during acolostomy takedown procedure.

[0009] The rigid post of the EEA stapler severely limits its use, aswell as requiring that an open procedure be utilized. The steerableendoscopic stapler is useful in allowing for more bowel accessibility;however, it remains dependent upon transabdominal surgical exposureprior to utilization. While laparoscopic surgical instruments have beenused for bowel anastomosis, in such procedures the bowel is exteriorizedthrough the laparoscopic incision and anastomosed extracorporeally or inan augmented stapled side-to-side fashion.

[0010] U.S. Pat. Nos. 5,868,760 and 6,264,086 describe a method andapparatus for performing endolumenal resection of tissue, in particularfor removal of diseased portions of a patient's colon. This purelyendolumenal approach to colostomy does not fully address the surgicalanatomy of the colon. As is well known, the colon and other viscera areconnected and supported within the abdomen by the omentum, a membranousextension of the peritoneum that carries the blood supply to the colon.Resection of more than a small portion of the colon requiresmobilization of the colon from the omentum and ligation or cauterizationof the blood vessels supplying that portion of the colon. This aspect isnot addressed by the endolumenal approach described; therefore it wouldbe suitable for resecting only small portions of the colon.

[0011] Commonly owned and copending U.S. patent application Ser. Nos.09/790,204 filed Feb. 20, 2001 (now U.S. Pat. No. 6,468,203); 09/969,927filed Oct. 2, 2001; and 10/229,577 filed Aug. 27, 2002, describesteerable colonoscopes that uses serpentine motion to facilitate rapidand safe insertion of the colonoscope into a patient's colon. Thetechnology described therein can also be used in conjunction with themethods and apparatus of the present invention to facilitate endoscopiccolectomy or resection of any other part of the gastrointestinal systemincluding, but not limited to, the esophagus, duodenum, jejunum andileum or any other tubular organ like the bronchus. These patents andpatent applications, and all other patents and patent applicationsreferred to herein, are hereby incorporated by reference in theirentirety.

SUMMARY OF THE INVENTION

[0012] In keeping with the foregoing discussion, the present inventiontakes the form of methods and apparatus for performing endoscopiccolectomy that combine the advantages of the laparoscopic andendolumenal approaches. The diseased portion of the colon to be resectedis identified using either laparoscopic and/or colonoscopic techniquesor using another imaging modality. A colectomy device mounted on acolonoscope grasps the colon wall at two sites adjacent to a diseasedportion of the colon. Using laparoscopic techniques, the diseasedportion of the colon is separated from the omentum and the blood vesselssupplying it are ligated or cauterized. The colon wall is transected toremove the diseased portion and the excised tissue is removed using thelaparoscope or drawn into the colectomy device for later removal uponwithdrawal of the colonoscope. The colectomy device approximates the twoends of the colon and performs an end-to-end anastomosis. If the part tobe resected is a tumor, prior to the resection, the edges of the segmentto be resected will be stapled to seal it and prevent spillage ofmalignant cells to the healthy tissue.

[0013] The methods and apparatus of the present invention provide anumber of benefits not realized by the prior art approaches tocolectomy. As stated above, the purely endolumenal approach does notprovide for separation of the colon from the omentum, which is necessarywhen resecting more than just a small portion of the colon wall. Bycombining laparoscopic techniques with a colonoscope-mounted colectomydevice, the present invention overcomes this deficiency in the prior artallowing a more comprehensive approach to colectomy. Unlike prior artlaparoscopic techniques, however, the colon does not need to beexteriorized for excision of the diseased portion or anastomosis of theremaining colon. The colonoscope-mounted colectomy device approximatesthe ends of the colon and performs an anastomosis from the interior ofthe lumen of the colon. The excised tissue can be drawn into thecolectomy device for removal through the lumen of the colon along withthe colonoscope or can be taken out by the laparoscope, which can bedone through a very small incision in the patient's skin. The prior artapproach also does not protect from leaking of malignant cells to theperiphery. This idea will enable sealing of the tissue with staples atits ends to prevent such leakage. Optionally, it will be done with thehelp of a laparoscopic device that will serve as an anvil. Unlike theprior art procedure, the present invention will optionally use a ballooninflated in the lumen of the colon or any other resected organ beforestapling, and by this assure the anastomosis will be ideal with the bestpossible approximation of the edges.

[0014] The use of colonoscopic techniques in the present inventionprovides another benefit not realized by a purely laparoscopic approach.Since colonoscopic examination is at present the most definitivediagnostic method for identifying diseases of the colon, locating thelesions through the exterior of the colon by laparoscopy or even bydirect visualization can be somewhat problematic. Using the colonoscopeto identify and isolate the diseased portion of the colon from withinthe lumen helps assure that the correct portions of the colon wall areexcised and makes clean surgical margins without residual disease moreassured as well.

[0015] In a preferred embodiment, the present invention utilizes asteerable colonoscope as described in U.S. patent application Ser. Nos.09/790,204 (now U.S. Pat. No. 6,468,203); 09/969,927; and 10/229,577,which have been incorporated by reference. The steerable colonoscopedescribed therein provides a number of additional benefits forperforming endoscopic colectomy according to the present invention. Thesteerable colonoscope uses serpentine motion to facilitate rapid andsafe insertion of the colonoscope into the patient's colon, which allowsthe endoscopic colectomy method to be performed more quickly and moresafely. Beyond this however, the steerable colonoscope has thecapability to create a three-dimensional mathematical model or map ofthe patient's colon and the location of any lesions identified duringthe initial examination. Lesions found during a previous examination byCT, MRI or any other imaging technology can also be mapped onto thethree-dimensional mathematical model of the colon. By generating athree-dimensional map of the colon, the system knows where each part ofthe endoscope is in the colon and will be able to localize the two partsof the dissecting and stapling system exactly in the desired location.During surgery, this information can be used to quickly and accuratelyreturn the colonoscope to the location of the identified lesions wherethe colonoscope-mounted colectomy device will be used to complete theendoscopic colectomy procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

[0016]FIG. 1 is a phantom drawing illustrating a diseased portion of thecolon being separated from the omentum using laparoscopic techniquesthrough a small incision in a patient's abdomen.

[0017]FIG. 2 is a cutaway drawing illustrating a steerable colonoscopewith a colectomy device mounted thereon being inserted through the lumenof a patient's colon.

[0018]FIG. 3 is a cutaway drawing showing the gripping mechanism of thecolonoscope-mounted colectomy device expanded within the lumen of thecolon.

[0019]FIG. 4 illustrates the colon after the diseased portion has beenexcised and removed with the colonoscope-mounted colectomy device inposition to approximate the transected ends of the colon.

[0020]FIG. 5 illustrates the colonoscope-mounted colectomy deviceperforming an end-to-end anastomosis to complete the endoscopiccolectomy procedure.

DETAILED DESCRIPTION OF THE INVENTION

[0021]FIG. 2 is a cutaway drawing illustrating a steerable colonoscope100 with a colectomy device 102 mounted thereon being inserted throughthe lumen of a patient's colon. As mentioned before, the same techniquemay apply for every other tubular shaped organ. Preferably, thesteerable colonoscope 100 is constructed as described in U.S. patentapplication Ser. Nos. 09/790,204 (now U.S. Pat. No. 6,468,203);09/969,927; and 10/229,577, with multiple articulating segments that arecontrolled to move with a serpentine motion that facilitates insertionand withdrawal of the colonoscope with a minimum of contact and stressapplied to the colon walls. In addition, the control system of thesteerable colonoscope 100 has the capability to construct athree-dimensional mathematical model or map of the colon as it advancesthrough lumen under control of the operator. The three-dimensionalmathematical model of the colon and the location and nature of anylesions identified in the course of an initial colonoscopic examinationcan be stored and used in performance of the endoscopic colectomyprocedure. In alternate embodiments, the colectomy device 102 of thepresent invention may be mounted on a colonoscope of a different designand construction.

[0022] The colectomy device 102 can be permanently or removably mountedon the steerable colonoscope 100. The colectomy device 102 has a distalcomponent 104 and a proximal component 106. The distal component 104 andthe proximal component 106 each have an expandable member 108 and agripping mechanism 110 for gripping the wall of the colon. Theexpandable member 108 may be an inflatable balloon or a mechanicallyexpandable mechanism. The gripping mechanism 110 may comprise aplurality of circumferentially located ports within which attachmentpoints 112, e.g., needles, hooks, barbs, etc., may be retractablypositioned about an exterior surface of the expandable member 108.Alternatively, the gripping mechanism 110 may utilize a vacuum gripperthrough a plurality of circumferentially located ports around the distalcomponent 104 and/or the proximal component 106 or other known grippingmechanisms. In the case of the vacuum gripper, gripping mechanism 110 isin fluid communication through the ports and through the colonoscope 100to the proximal end of the colonoscope 100 to a vacuum pump (not shown).At least one, and optionally both, of the distal component 104 and theproximal component 106 are movable longitudinally with respect to thebody of the steerable colonoscope 100. Rails, grooves or the like 114may be provided on the body of the steerable colonoscope 100 for guidingthe longitudinal movement of the distal component 104 and the proximalcomponent 106.

[0023] In addition, the colectomy device 102 includes a surgical stapler116 or other anastomosis mechanism. The surgical stapler 116 is carriedon either the distal component 104 or the proximal component 106 and astapler anvil 118 is carried on the other of these components. Thesurgical stapler 116 may be configured similarly to any number ofconventional stapling devices which are adapted to actuate staples intotissue. Another option is that there is a stapler and an anvil on bothcomponents for stapling and sealing the edges. Optionally, the colectomydevice 102 may include a cutting device and/or electrocautery and/or alaser device for transecting the colon wall. Optionally, the colectomydevice 102 may also include a vacuum mechanism or the like for drawingthe excised tissue into the colectomy device 102 for later removal alongwith the steerable colonoscope 100.

[0024]FIG. 2 shows the steerable colonoscope 100 with the expandablemembers 108 of the distal component 104 and the proximal component 106in a contracted or deflated condition for easy passage through the lumenof the patient's colon. The control system of the steerable colonoscope100 monitors the position of each segment of the colonoscope 100 as itis advanced within the colon and can signal to the operator when thesegments carrying the distal component 104 and the proximal component106 of the colectomy device 102 are correctly positioned with respect toa previously detected lesion in the colon. Alternatively, the controlsystem of the steerable colonoscope 100 can be programmed to advance thecolonoscope 100 automatically through the lumen of the colon and to stopit when the distal component 104 and the proximal component 106 of thecolectomy device 102 are correctly positioned with respect to the lesionin the colon. Alternatively, the control system will be able toautomatically guide and deliver the two components to the desiredlocation after the colonoscope has been inserted to the colon.

[0025]FIG. 3 is a cutaway drawing showing the expandable members 108 ofthe distal component 104 and the proximal component 106 of thecolonoscope-mounted colectomy device 102 expanded within the lumen ofthe colon so that the gripping mechanism 110 grips the wall of thecolon. The distal component 104 and the proximal component 106 may beexpanded through any number of expansion devices. For instance, they maybe radially expanded upon spoke-like support structures or they may beconfigured to radially expand in a rotational motion until the desiredexpansion diameter is attained. At this point, with the diseased portionof the colon identified and isolated by the colonoscope-mountedcolectomy device 102, the diseased portion is separated from the omentumand the blood vessels supplying it are ligated and/or cauterized usinglaparoscopic techniques. FIG. 1 is a phantom drawing illustrating adiseased portion of the colon being separated from the omentum usinglaparoscopic techniques through a small incision in a patient's abdomen.

[0026] Next, the diseased portion of the colon is excised by transectingthe colon at the proximal and distal end of the diseased portion. Thecolon may be transected using laparoscopic techniques or using a cuttingmechanism and/or electrocautery device mounted on the colectomy device102. The excised tissue is removed using the laparoscope or drawn intothe colectomy device 102 for later removal upon withdrawal of thesteerable colonoscope 100. FIG. 4 illustrates the colon after thediseased portion has been excised and removed with thecolonoscope-mounted colectomy device 102 in position to approximate thetransected ends of the colon.

[0027] The remaining ends of the colon are approximated one to the otherby moving the distal component 104 and/or the proximal component 106longitudinally with respect to the body of the steerable colonoscope100, as shown by the arrows. Optionally, the proximal component 106 maybe longitudinally translated towards the distal component 104 or bothcomponents 104, 106 may be approximated simultaneously towards oneanother. The ends of the colon are stapled to one another to create anend-to-end anastomosis 120 using the surgical stapler 116 and stapleranvil 118 on the colectomy device 102. Once the ends of the tissue havebeen approximated, staples or other fastening devices, e.g., clips,screws, adhesives, sutures, and combinations thereof, etc., may beactuated through the surgical stapler 116 such that they pierce bothends of the tissue against the stapler anvil 118. FIG. 5 illustrates thecolonoscope-mounted colectomy device performing an end-to-endanastomosis 120 to complete the endoscopic colectomy procedure. Once theanastomosis 120 is complete, the expandable members 108 of the distalcomponent 104 and the proximal component 106 are deflated or contractedand the steerable colonoscope 100 and the colectomy device 102 arewithdrawn from the patient's body. The expanded members will assure avery accurate end-to-end anastomosis and prevent stenosis that canhappen as a result of inaccurate approximation of the two ends.

[0028] In an alternative method using the colonoscope-mounted colectomydevice 102, the diseased portion of the colon may be excised using acutting device within the colectomy device 102 after the ends of thediseased portion have been approximated and anastomosed. The excisedtissue is drawn into the colectomy device 102 and removed when thesteerable colonoscope 100 is withdrawn from the patient.

[0029] In another alternative method, the colectomy procedure may beperformed entirely from the endolumenal approach using thecolonoscope-mounted colectomy device 102 without laparoscopicassistance. This method would be particularly advantageous for resectionof small portions of the colon where it may not be necessary to mobilizean extended portion of the colon from the omentum to achieve successfulapproximation and anastomosis. The three-dimensional mapping capabilityof the steerable colonoscope 102 would be used to locate previouslyidentified lesions without laparoscopic assistance.

[0030] While the present invention has been described herein withrespect to the exemplary embodiments and the best mode for practicingthe invention, it will be apparent to one of ordinary skill in the artthat many modifications, improvements and subcombinations of the variousembodiments, adaptations and variations can be made to the inventionwithout departing from the spirit and scope thereof.

I claim:
 1. An endoscopic device for approximating tissue within ahollow body organ, comprising: an elongated body having a plurality ofarticulatable segments and a steerable distal portion, wherein each ofthe segments are configurable to assume a selected shape along anarbitrary path when the elongated body is advanced distally orproximally; a first tissue approximation component positioned about theelongated body, wherein the first component is adapted to radiallyexpand and adhere a first region of tissue to a plurality of tissuegripping regions circumferentially located about the first component;and a second tissue approximation component positioned about theelongated body proximally of the first component, wherein the secondcomponent is adapted to radially expand and adhere a second region oftissue to a plurality of tissue gripping regions circumferentiallylocated about the second component, wherein the first component and thesecond component are adapted to approximate and securely fasten thefirst region to the second region of tissue.
 2. The endoscopic device ofclaim 1 wherein the first and the second tissue approximation componentseach comprise a radially expandable ring.
 3. The endoscopic device ofclaim 1 wherein the first and the second tissue approximation componentseach comprise a radially expandable balloon.
 4. The endoscopic device ofclaim 1 wherein the plurality of tissue gripping regions on each of thefirst and the second tissue approximation components comprise vacuumports.
 5. The endoscopic device of claim 1 wherein the plurality oftissue gripping regions on each of the first and the second tissueapproximation components comprise retractable fasteners.
 6. Theendoscopic device of claim 5 wherein the retractable fasteners areselected from the group consisting of needles, hooks, and barbs.
 7. Theendoscopic device of claim 1 wherein the first tissue approximationcomponent is adapted to slide longitudinally towards the second tissueapproximation component along at least a portion of the elongated bodywithin rails or grooves defined along the elongated body such that thefirst region is adjacent to the second region of tissue.
 8. Theendoscopic device of claim 1 wherein the second tissue approximationcomponent is adapted to slide longitudinally towards the first tissueapproximation component along at least a portion of the elongated bodywithin rails or grooves defined along the elongated body such that thefirst region is adjacent to the second region of tissue.
 9. Theendoscopic device of claim 1 wherein the first and the second tissueapproximation components are each adapted to slide longitudinallytowards one another along at least a portion of the elongated bodywithin rails or grooves defined along the elongated body such that thefirst region is adjacent to the second region of tissue.
 10. Theendoscopic device of claim 1 wherein the first or the second tissueapproximation component contains a plurality of fasteners adapted tofasten the first region to the second region of tissue.
 11. Theendoscopic device of claim 10 wherein the fasteners are selected fromthe group consisting of staples, clips, screws, adhesives, sutures, andcombinations thereof.
 12. A method of endoscopically approximatingtissue within a hollow body organ, comprising: positioning an elongatedbody adjacent to a portion of tissue to be excised from the hollow bodyorgan; releasably fastening a first region of tissue circumferentiallyabout a first tissue approximation component and a second region oftissue circumferentially about a second tissue approximation componentsuch that the tissue to be excised is positioned between the first andthe second tissue approximation components; removing the tissue to beexcised from between the first and the second tissue approximationcomponents; approximating the first and the second tissue approximationcomponents such that the first and the second regions of tissue areadjacent to one another; and fastening the first region of tissue to thesecond region of tissue.
 13. The method of claim 12 wherein the firstand the second regions of tissue are releasably fastened to the firstand the second tissue approximation components, respectively, via avacuum force.
 14. The method of claim 12 wherein the first and thesecond regions of tissue are releasably fastened to the first and thesecond tissue approximation components, respectively, via a plurality offasteners.
 15. The method of claim 14 wherein the fasteners areretractable.
 16. The method of claim 12 wherein releasably fasteningcomprises radially expanding the first and the second tissueapproximation components into contact with the first and the secondregions of tissue, respectively.
 17. The method of claim 12 whereinremoving the tissue to be excised comprises laparoscopically excisingthe tissue from between the first and the second tissue approximationcomponents.
 18. The method of claim 12 wherein approximating the firstand the second tissue approximation components comprises longitudinallytranslating the first and the second tissue approximation componentstowards one another along the elongated body.
 19. The method of claim 12wherein fastening the first region of tissue to the second region oftissue comprises stapling or suturing the first region to the secondregion via the first or the second tissue approximation component. 20.The method of claim 12 further comprising radially reducing a diameterof the first and the second tissue approximation components.